MAUDE Adverse Event Report: ENCORE MEDICAL L.P. ALTIVATE SHOULDER; ENCORE REVERSE SHOULDER HUMERAL STEM, STD, SZ10X108MM

Model Number 530-10-108

Device Problem Unstable (1667)

Patient Problem Failure of Implant (1924)

Event Date 11/14/2017

Event Type  Injury  

Event Description

Second revision surgery - due to instability, not due to any failure of djo product.

Manufacturer Narrative

The reason for this revision surgery was due to instability.The in-vivo length of patient service for the implant was 3.5 months.There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery.There are no reported pre-existing patient health conditions.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was disposed of at the hospital and not made available to djo surgical for examination.A review of the implant device history records (dhr), shows that the reported components used in the previous surgery met design and manufacturing requirements.There were no ncmrs associated with the products that may have contributed to the instability.The device and its applicable concomitant devices were verified to have gone through acceptable sterilization processes and were within their respective expiration dates at the time of use during the previous surgery.Customer complaint history of the reported device(s) showed no present trends or on-going issues that are in need of review.This event is deemed to be non-product related.The root cause of this complaint was a revision surgery due to instability.No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the dislocation.There are multiple factors that may contribute to a dislocation that are outside of the control of djo surgical.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: ALTIVATE SHOULDER
• Type of Device: ENCORE REVERSE SHOULDER HUMERAL STEM, STD, SZ10X108MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• Manufacturer Contact: teffany hutto ; 9800 metric blvd.; austin, TX 78758-5445
• MDR Report Key: 7084591
• MDR Text Key: 93778007
• Report Number: 1644408-2017-01111
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912168366
• UDI-Public: (01)00888912168366
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2023
• Device Model Number: 530-10-108
• Device Catalogue Number: 530-10-108
• Device Lot Number: 409T1186
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/14/2017
• Initial Date FDA Received: 12/05/2017
• Supplement Dates Manufacturer Received: 01/02/2018
• Supplement Dates FDA Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 508-36-101, LOT 869C2275; 509-01-436, LOT 390P1018
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR